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  • NARCAN® Naloxone HCl Nasal Spray 4 mg is currently the first and only prescription strength naloxone nasal spray to receive over-the-counter status in the U.S., which is a critical step toward broadening access
  • Expected over-the-counter availability is anticipated by late summer of this year

GAITHERSBURG, Md., March 29, 2023 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved NARCAN® Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC) emergency treatment of opioid overdose. This decision comes at a time when approximately every eight minutes, a person dies from an opioid overdose and research shows the epidemic is escalating in the U.S. with the rise in synthetic opioids. By offering NARCAN® Nasal Spray as an OTC treatment, anyone will be able to access it without a prescription, which is an important step in the fight to reduce the number of opioid overdose deaths occurring each day.

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MARCH 28, 2023 - GAITHERSBURG, Md., (BUSINESS WIRE) -- Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $35 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment will be used to advance and accelerate lead candidate JK07, including the planned initiation of the first Phase 2 study in HFrEF, the continuation of the ongoing Phase 1b clinical trial in heart failure with preserved ejection fraction (HFpEF), and the launch of the Company’s first neurology clinical trial with JK07. The financing will also support the ongoing Phase 1/2 trial of JK08 in solid tumors and advance JK06, a pre-clinical biparatopic antibody-drug conjugate, into an initial Phase 1/2 study.

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Leiden, the Netherlands , March 28, 2023 / B3C newswire / -- MIMETAS, a global leader in human disease modeling announces that it has entered into a strategic partnership with Astellas Pharma Inc., a global pharmaceutical company. The partnership comprises utilizing MIMETAS’ comprehensive tumor models to support the next generation of immuno-oncological therapies.

Vishal and Rich

Ready to explore the frontiers of cancer therapeutics? Discover how AUM Biosciences, with a key presence in Montgomery County, Maryland, in the BioHealth Capital Region, is revolutionizing the development of innovative oncology medicines and transforming the fight against cancer resistance. Join us on this episode of BioTalk with Rich Bendis as we chat with Vishal Doshi, Chairman & CEO of AUM Biosciences, a visionary leader in the biotech industry. Tune in to the conversation that's sparking new hope in the battle against cancer.

Listen now via your favorite podcast platforms: Apple - https://apple.co/42LvH4A Google - https://bit.ly/40yTOBC Spotify - https://spoti.fi/40F2NkV Amazon Music - https://amzn.to/40hFz4L TuneIn - https://bit.ly/42Gpfff YouTube - https://bit.ly/3TMIuji

Macrogenics

ROCKVILLE, MD, March 22, 2023 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today reported that following the U.S. Food and Drug Administration's (FDA) approval of Incyte's Biologics License Application (BLA) for ZYNYZ™ (retifanlimab-dlwr), the Company will receive a $15 million milestone payment from Incyte. ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017.

BioBuzz FITCI Partnership

MARYLAND, March 23, 2023 — BioBuzz, the media outlet of Workforce Genetics, and the Frederick Innovative Technology Center, Inc. (FITCI) have announced a strategic partnership to fuel industry growth in the BioHealth Capital Region and growth for both parties.

FITCI CEO Kathie Callahan Brady says she is excited to move forward. “We both focus on the biotech space, but the perspective is different. It is exactly the type of collaboration we want to infuse into our new EDGE@321 entrepreneurial innovation center opening later this year, bridging competencies and markets to strengthen the whole community.”

Image: https://biobuzz.io

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There has been a smoldering fire on the geopolitical stage that, if we continue to ignore, we risk allowing it to spread and burn its surrounding environment. I’m referring to the convergence of multiple technology revolutions with the high-stakes competition between the United States and a rising authoritarian competitor in China.

 

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Event provides forum for researchers to learn more about ARPA-H’s Open Broad Agency Announcement

ARPA-H has opened its first Agency-wide Open BAA, seeking funding proposals for research aiming to improve health outcomes across patient populations, communities, diseases, and health conditions.

On April 4, ARPA-H will host a Proposers’ Day for interested parties to learn more about the application process for the Open BAA and ask questions. Register for the event. (Registration closes 5 p.m. ET on Monday, March 3)

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MARYLAND, March 23, 2023 — BioBuzz, the media outlet of Workforce Genetics, and the Frederick Innovative Technology Center, Inc. (FITCI) have announced a strategic partnership to fuel industry growth in the BioHealth Capital Region and growth for both parties.

FITCI CEO Kathie Callahan Brady says she is excited to move forward. “We both focus on the biotech space, but the perspective is different. It is exactly the type of collaboration we want to infuse into our new EDGE@321 entrepreneurial innovation center opening later this year, bridging competencies and markets to strengthen the whole community.”

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Riley-Brown will succeed Kurt Newman, M.D., who has served in role for over 11 years

March 23, 2023

The Children’s National Board of Directors announced today that Michelle Riley-Brown, MHA, FACHE, has been named as the new president and chief executive officer (CEO) of Children’s National Hospital. On July 1, Riley-Brown will succeed Kurt Newman, M.D., who is retiring after 11 years as president and CEO.

Riley-Brown is an accomplished executive with over 20 years of experience leading and supporting children’s healthcare. She is currently an executive vice president at Texas Children’s Hospital at the Texas Medical Center in Houston, where she serves concurrently as the president of two hospitals in the system while leading the construction and staffing of a third. She also leads system-level operations, strategic planning, physician practice acquisition, quality performance, clinical operations, fund development, marketing, brand management and public relations for the nation’s largest pediatric and women’s healthcare organization.

Vishal Doshi is the founder and CEO of AUM Biosciences.
Photo: AUM Biosciences.

Whenever someone asks about dreams, there is an underlying expectation that it is something that springs up on you at a nascent age, like an epiphany where you’ve realised your life’s calling. But that is not always the case. For me, founding a global biotechnology company was not an overnight phenomenon, but a dream that gradually materialised as I started helping at my family’s pharmacy when I was eight.

Image: Vishal Doshi is the founder and CEO of AUM Biosciences. Photo: AUM Biosciences.

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At Johnson & Johnson Innovation – JLABS, part of our mission is to bring big company benefits to entrepreneurs and startups, along with our network. We also know that networks really do matter when it comes to access to capital.

In leaning into our mission, on March 9th, we brought together more than 30 startup companies and 30 investors from across the US and Canada to JLABS @ Washington, DC for our second annual Johnson & Johnson Innovation – JLABS East North America Investor & Partnering Event.

 

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Leiden, March 3, 2023 – MIMETAS has achieved major milestones in its partnership with Roche, developing models for Inflammatory Bowel Disease (IBD) and Hepatitis B Virus infections (HBV).

In July 2021, MIMETAS and Roche entered a risk-sharing collaboration to develop human disease models for the characterization of novel compounds in Inflammatory Bowel Disease (IBD) and Hepatitis B virus infections (HBV). You can find the original press release here.

Image: https://www.mimetas.com

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March 22, 2023 - The BioHealth Capital Region (BHCR) with The District of Columbia, Maryland, and Virginia are making a name for themselves as some of the most innovative states in the nation, according to a new study by WalletHub. All three have secured spots in the Top 10 of WalletHub's 2022 rankings of the Most Innovative States. This recognition highlights the region's strength as a hub for innovation and technological advancement.

The study compared all 50 states and the District of Columbia across 24 key indicators of innovation-friendliness, including research and development spending per capita, the share of STEM professionals, and tech company density. The District of Columbia took the top spot overall, with Maryland coming in at number 5 and Virginia rounding out the top 10 at number 9. These strong rankings reflect the region's commitment to fostering a culture of innovation and investing in developing cutting-edge technologies.

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GAITHERSBURG, MD / ACCESSWIRE / February 16, 2023 / BullFrog AI Holdings, Inc. (NASDAQ:BFRG; BFRGW) ("Bullfrog AI" or the "Company"), a digital technology company using machine learning to usher in a new era of precision medicine, announced today the closing of its initial public offering of 1,297,318 units (each, a "Unit," collectively, the "Units") at a price of $6.50 per unit for a total of approximately $8.4 million of gross proceeds to the Company. Each Unit consists of one share of the Company's common stock, one tradeable warrant (each, a "Tradeable Warrant," collectively, the "Tradeable Warrants") to purchase one share of common stock at an exercise price of $7.80 per share, and one non-tradeable warrant (each, a "Non-tradeable Warrant," collectively, the "Non-tradeable Warrants"; together with the Tradeable Warrants, each, a "Warrant," collectively, the "Warrants") to purchase one share of the Company's common stock at an exercise price of $8.125.

 

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Hot off the press: TSESSEBE Technologies Won $5,000 at the #NCBCP Black Women's Roundtable event. Our sincere appreciation to #bwrsummit23 leadership and The Coca-Cola Company for investing this seed award in us this #womenshistorymonth! #TSESSEBETech is taking it to the TOP leveraging technology to empower, liberate, and revolutionize the personalized health landscape and the health data ownership paradigm. First stop, #ooTANOBC for Breast Cancer Health, and soon breaking ground in other diseases and spheres of life REIMAGINing paradigm and practice as we ACT! Dee C. Marshall, Tameka M. Ramsey, MPA, BSW, Melanie Campbell, Tonya Tyson - we couldn't have done it without you, THANK YOU. For my SiStars and our Women around the world, we remain undaunted! #technology #innovation #leadership #breastcancer #health #healthequity

 

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Advanced Research Projects Agency for Health (ARPA-H) has recently opened its first Agency-wide Open Broad Agency Announcement (BAA), which seeks funding proposals for research to improve health outcomes across patient populations, communities, diseases, and health conditions. The BAA calls for proposals that outline breakthrough research and technological advancements, investigate unconventional approaches, and challenge accepted assumptions to enable leaps forward in science, technology, systems, or related capabilities. ARPA-H also encourages concepts that advance the objectives of President Biden's Cancer Moonshot initiative, as well as more disease-agnostic approaches.​

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Join us for a lunch and learn to hear how new technologies in quantum computing will be utilized to power scientific research and the life science companies already taking advantage. Shahar Keinan, CEO, and Maurice Benson, Lead Software Engineer at POLARISqb, will give a presentation on how the innovations in the quantum computing industry will directly impact the future of drug design, clinical research, and precision medicine. POLARISqb has created one of the first platforms for the life sciences industry that can cut the drug discovery research process timeline from its traditional time of 5 years down to 4 months. Shahar and Maurice will also discuss how quantum computers are beginning to be made ready for commercial use and all of the recent case studies on their performance.

Image: https://www.eventbrite.com

Giorgio Trovato/Unsplash, Jesse Bowser/Unsplash

The tragic and shocking demise of SVB and bailout of its depositors is a watershed, “Too Big to Fail” event for Silicon Valley that will reverberate for years to come, if not longer, bringing significant new challenges to the industry in both the short and long term.

For the small but critically important world of startups and venture capital, things have gone from bad to worse. After a year of upheaval—plummeting stock valuations, dormant M&A and IPO markets, and massive layoffs—the tech industry now bears the indignity of losing a cherished institution that nearly sparked a national financial panic.

Image: Giorgio Trovato/Unsplash, Jesse Bowser/Unsplash

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The collapse of Silicon Valley Bank (SVB) on Friday, March 10, sent shockwaves through the tech and biotech world. But it does not appear to have had a major effect on the BioHealth Capital Region and the Philadelphia region’s life sciences industry, at least not so far.

On about March 8, SVB, a major supporter of tech, biotech and venture capital funds, indicated it was facing a cashflow problem. Initially, it attempted to raise money by selling shares. Then it attempted to sell itself. Investors were alarmed by these efforts and began pulling their funds from the bank, causing a run on the bank, leading to shares plunging on Thursday, March 9. On Friday, March 10, regulators shut down the bank.

Image: https://biobuzz.io/

RoosterBio

FREDERICK, Md., March 13, 2023 /PRNewswire-PRWeb/ -- RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, development services, cell engineering, and advanced therapy bioprocess solutions, today announced that it has selected Repligen Corporation, a life sciences company focused on bioprocessing technology leadership, as a collaboration partner to advance scalable exosome bioprocessing.

RoosterBio's goal, in collaboration with Repligen, is to deliver solutions for manufacturing of exosomes using scalable and low shear technologies that enable cost-effective commercialization of these advanced therapies.

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Want to be on the cutting edge of disease treatment? Learn how companies like Immunyx Pharma are changing the landscape of immune modulation in the battle against diseases with the JLABS/BARDA Blue Knight program on this episode of BioTalk with Rich Bendis.

Also Available on popular podcast platforms like Apple https://apple.co/3LlbxIy, Google https://bit.ly/3l6O6ba, Spotify https://spoti.fi/405ln5B, Amazon Music https://amzn.to/3J58kde, TuneIn https://bit.ly/3JA8MBO, and even YouTube https://bit.ly/3LhYZS6.

Mimetas

LEIDEN, the Netherlands, March 07 / B3C newswire / -- MIMETAS, a leading company in the field of organ-on-a-chip-based disease models, announces that it has launched its Adult Stem Cell (ASC)-derived tubular organoids in an assay-ready format. As part of its OrganoReady® product line, MIMETAS offers two organoid-based products: ASC-derived Colon1 and Kidney2 Organoid tubules.

“We are thrilled to offer this cutting-edge technology to the research community,” says Jos Joore, co-CEO of MIMETAS. “We’ve worked for several years to optimize these OrganoReady® organoid products. As a result, our early-access users will be the first in the world to have license-free access to ready-to-use, donor-relevant organoid tubules of consistent quality.”

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In the field of artificial intelligence, there are winters and there are springs—barren stretches followed by exhilarating bursts of innovation and funding. Right now, we find ourselves definitively in the midst of an AI spring, says Johns Hopkins engineer Rama Chellappa, a veteran of the industry for more than four decades.

 

Mona

ROCKVILLE, MARYLAND, March 8, 2023 BioHealth Innovation Inc. (BHI) is pleased to welcome Mona Suliman, Ph.D., as a new Life Sciences Business Strategist. In this role, Mona will evaluate the commercial potential of clients’ emerging technologies and assist start-ups with their go-to-market strategies. Her work will also focus on helping biohealth companies to secure non-dilutive funding.

Mona Suliman has been a consultant in the business and science sectors for over eight years. Her specific areas of focus are entrepreneurship, innovation, strategy, and marketing. She obtained her Master’s in Business Administration from George Mason University and her Ph.D. in Biochemistry from Virginia Commonwealth University in Richmond. As a consultant, she supported companies in developing marketing strategies and creating product launch plans and development strategies.

“We are thrilled to welcome Mona to BHI,” said Richard Bendis, BHI President, and CEO. “I am confident Mona will bring a unique perspective and energy to our team and BioHealth Partners.”

About BioHealth Innovation, Inc. 

BioHealth Innovation, Inc. (BHI) is a public-private nonprofit organization focused on accelerating biohealth (therapeutic, diagnostic, medtech, and health IT) commercialization in the BioHealth Capital Region (Maryland, DC, and Virginia).

www.BioHealthInnovation.org

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Media contacts:
Rich Bendis
Phone: 301-637-6439, email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Lucy and Rich Gif

Lucy Alexander, Capabilities Lead, Global Supply Chain & Strategy with AstraZeneca, joins Rich Bendis on BioTalk to discuss leading world-class supply chain operations, developing new strategies, and the continued growth of AZ in the BioHealth Capital Region.

Listen via Apple https://apple.co/3Zov7b7, Google https://bit.ly/3JfYiav, Spotify https://spoti.fi/3ZGPekn, Amazon Music https://amzn.to/3ZqknsP, and TuneIn http://bit.ly/2M60Wmx.

Sarah Miller, MS

The BioHealth Innovation, Inc. (BHI) team would like to extend its deepest gratitude to Sarah Miller, Vice President of Economic Development, for her invaluable contributions to the organization as she moves on to a new opportunity. Sarah has played an integral role in BHI's mission to accelerate the commercialization of BioHealth technologies and worked tirelessly to build and maintain strong relationships with industry stakeholders and partners. Her dedication and hard work will be greatly missed, and we wish her all the best in her future endeavors.

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The Shady Grove Innovation District is a planned mixed-use, transit-served innovation ecosystem of more than 1.3M SF located in Maryland’s premier life sciences cluster.

BXP, formerly Boston Properties, recently unveiled plans at its pre-application community meeting to develop the Shady Grove Innovation District (“SGID”), a world-class, amenity-rich, mixed-use district catering to the dynamic life science industry in the heart of the Shady Grove cluster in Rockville, Maryland.  SGID will initially include 150,000 square feet of lab/R&D space in a five-story building and 315 luxury apartments. The district has the potential to grow to more than 1.3M square feet of lab/R&D space across a total of nine buildings.  Construction could begin as early as mid-2024.

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Join us for a lunch and learn to hear how new technologies in quantum computing will be utilized to power scientific research and the life science companies already taking advantage. Shahar Keinan, CEO, and Maurice Benson, Lead Software Engineer at POLARISqb, will give a presentation on how the innovations in the quantum computing industry will directly impact the future of drug design, clinical research, and precision medicine. POLARISqb has created one of the first platforms for the life sciences industry that can cut the drug discovery research process timeline from its traditional time of 5 years down to 4 months. Shahar and Maurice will also discuss how quantum computers are beginning to be made ready for commercial use and all of the recent case studies on their performance.

 

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Join Maryland Technology, a division of the Maryland Tech Council, for our fourth annual Digital Transformation Summit on March 16, 2023. The event will be held in-person at The Hotel at Arundel Preserve, Hanover, Maryland.

The Digital Transformation Summit brings Maryland-based technology organizations and professionals together to educate one another regarding the newest and most exciting technologies of the day, and to discuss and find ways to collaborate on the most relevant emerging or growing technologies and industry trends.

 

Regulatory

The Evolution of Gap Assessments, Remote Audits, Inspection Readiness and Remediation during the Covid 19 Pandemic

The Covid 19 pandemic created immense challenges for the Pharmaceutical, Biopharmaceutical and Medical Device Industries, and for companies researching, developing, and manufacturing Rx products around the world. In 2020 and 2021 (and to some degree, continuing today) all processes were dramatically impacted by the pandemic as many employees, consultants, and others were restricted from physically working in the office or manufacturing facility, resulting in skeleton crews and largely remote workers.